Xagrid 500microgram capsules

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Anagrelide hydrochloride

Tillgänglig från:

Shire Pharmaceuticals Ltd

ATC-kod:

L01XX35

INN (International namn):

Anagrelide hydrochloride

Dos:

500microgram

Läkemedelsform:

Capsule

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 09010400; GTIN: 5022690031763

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
XAGRID 0.5 MG HARD CAPSULES
anagrelide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Xagrid is and what it is used for
2.
What you need to know before you take Xagrid
3.
How to take Xagrid
4.
Possible side effects
5.
How to store Xagrid
6.
Contents of the pack and other information
1.
WHAT XAGRID IS AND WHAT IT IS USED FOR
Xagrid contains the active substance, anagrelide. Xagrid is a medicine
which interferes with the
development of platelets. It reduces the number of platelets produced
by the bone marrow, which
results in a decrease in the platelet count in the blood towards a
more normal level. For this reason it is
used to treat patients with essential thrombocythaemia.
Essential thrombocythaemia is a condition which occurs when the bone
marrow produces too many of
the blood cells known as platelets. Large numbers of platelets in the
blood can cause serious problems
with blood circulation and clotting.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XAGRID
DO NOT TAKE XAGRID

If you are allergic to anagrelide or any of the other ingredients of
this medicine (listed in section
6). An allergic reaction may be recognised as a rash, itching, swollen
face or lips, or shortness
of breath;

If you have moderate or severe liver problems;

If you have moderate or severe kidney problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Xagrid:

If you have or think you might have a problem with your heart;

If you were born with or

Produktens egenskaper

OBJECT 1
XAGRID 0.5MG HARD CAPSULE
Summary of Product Characteristics Updated 16-May-2018 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
Xagrid 0.5 mg hard capsules.
2. Qualitative and quantitative composition
Each hard capsule contains 0.5 mg anagrelide (as anagrelide
hydrochloride).
Excipient(s) with known effect
Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous
lactose (65.8 mg).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Hard capsule.
An opaque white hard capsule imprinted with S 063.
4. Clinical particulars
4.1 Therapeutic indications
Xagrid is indicated for the reduction of elevated platelet counts in
at risk essential thrombocythaemia
(ET) patients who are intolerant to their current therapy or whose
elevated platelet counts are not reduced
to an acceptable level by their current therapy.
An at risk patient
An at risk essential thrombocythaemia patient is defined by one or
more of the following features:
• > 60 years of age or
• a platelet count > 1000 x 10
9
/l or
• a history of thrombo-haemorrhagic events.
4.2 Posology and method of administration
Treatment with Xagrid should be initiated by a clinician with
experience in the management of essential
thrombocythaemia.
Posology
The recommended starting dose of anagrelide is 1 mg/day, which should
be administered orally in two
divided doses (0.5 mg/dose).
The starting dose should be maintained for at least one week. After
one week the dose may be titrated, on
an individual basis, to achieve the lowest effective dose required to
reduce and/or maintain a platelet
count below 600 x 10
9
/l and ideally at levels between 150 x 10
9
/l and 400 x 10
9
/l. The dose increment
must not exceed more than 0.5 mg/day in any one-week and the
recommended maximum single dose
should not exceed 2.5 mg (see section 4.9). During clinical
development doses of 10 mg/day have been
used.
The effects of treatment with anagrelide must be monitored on a
regular basis (see section 4.4). If the
starting dose is >